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PhRMA on FDA social guidances


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Industry groups PhRMA and BIO are reviewing the recent FDA draft guidances on space-limited social media and correcting misinformation.

Jeffrey K. Francer, VP and Senior Counsel with PhRMA

“The companies want to provide information that’s useful to physicians and that’s useful to patients, and they should be able to use all the different media that the government uses itself,” Francer said. “I assume that the FDA believes that its own tweets are truthful and not misleading. If they believe that, then why couldn’t a company use Twitter in the same way that the FDA is using Twitter?”

Glenn M. Engelmann, a senior counsel with the law firm McDermott Will & Emery

I suspect you’ll see companies being more engaged in social media than they have in the past. I suspect given the volume of commentary out there, they will inevitably be selective as to which forums that they participate in,” said Engelmann, who is vice chair of the law firm’s Life Sciences Industry Group and a former member of AstraZeneca’s executive leadership team responsible for managing the U.S. business. “Until now, companies have held back in terms of correcting misinformation because they were not confident as to how FDA would treat their involvement.” … “What I think it does do is unshackle companies a bit to get more active in a real-time way in social media without fear of running afoul of FDA and incurring any adverse regulatory consequences.”

This adds to the industry chatter about these draft guidances. Read our take on the webinar from last week that had significant technical issues but that didn’t really change the interpretation of the draft guidances.

Source: GEN

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